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    Summary
    EudraCT Number:2011-002393-23
    Sponsor's Protocol Code Number:CSL627_1001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002393-23
    A.3Full title of the trial
    A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: octocog alfa) in Subjects with Hemophilia A, and a Repeat PK, Safety and Efficacy Study
    Studio di fase I/III in aperto, multicentrico, incrociato sulla sicurezza, l'efficacia e la farmacocinetica del Fattore VIII della Coagulazione Ricombinante (rFVIII) in comparazione con il Fattore VIII Ricombinante Umano Antiemofilico (rFVIII; INN: octocog alfa) in soggetti con Emofilia A, ed uno studio sulla farmacocinetica ripetuta, sulla sicurezza e l'efficacia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety and effectiveness of a new treatment from human blood source that replaces the missing clotting factor VIII, including determination of drug level in hemophilia A patients.
    Studio sulla sicurezza ed efficacia di un nuovo trattamento ricavato da sangue umano che sostituisce il fattore di coagulazione VIII mancante e teso a determinare la concentrazione del farmaco in pazienti con emofilia A.
    A.4.1Sponsor's protocol code numberCSL627_1001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCSL BEHRING GMBH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCSL Behring GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring GmbH
    B.5.2Functional name of contact pointSr. Clinical Program Manager
    B.5.3 Address:
    B.5.3.1Street AddressEmil-von-Behring-Str. 76
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35041
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 6421392930
    B.5.5Fax number+49 6421393172
    B.5.6E-mailkerstin.jung@cslbehring.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRecombinant Factor VIII (rFVIII)
    D.3.2Product code CSL627
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCSL627 or rFVIII
    D.3.9.3Other descriptive nameFattore VIII di coagulazione ricombinante
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Advate
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter HealthCare Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTOCOG ALFA
    D.3.9.1CAS number 139076-62-3
    D.3.9.4EV Substance CodeSUB16449MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hemophilia A.
    Emofilia A
    E.1.1.1Medical condition in easily understood language
    Hemophilia A is a rare but serious bleeding disorder which affects males and is characterized by a deficiency in the plasma protein known as coagulation Factor VIII.
    L'emofilia A è un raro ma serio disordine emorragico che colpisce i maschi ed è caratterizzato da una mancanza di una proteina del sangue conosciuta cone Fattore VIII di coagulazio
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10060612
    E.1.2Term Hemophilia A
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the PK profile of CSL627. To demonstrate efficacy in the prevention and treatment of bleeding events. To demonstrate the efficacy of CSL627 in surgical prophylaxis. Characterize the rate of inhibitor formation.
    definire il profilo farmacocinetico (PK) di CSL627; • dimostrarne l’efficacia nella prevenzione e nel trattamento degli eventi di sanguinamento; • dimostrare l’efficacia di CSL627 nella profilassi chirurgica; • determinare il tasso di formazione di inibitori.
    E.2.2Secondary objectives of the trial
    To characterize the safety profile of CSL627. To establish the PK comparison of CSL627 to octocog alfa.
    definire il profilo di sicurezza di CSL627; • confrontare la farmacocinetica di CSL627 a quella di octocog alfa.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    An evaluation of the safety and efficacy of CSL627 in the prevention andtreatment of bleeding during surgical procedures. Main objective of substudy: to demonstrate the efficacy of CSL627in surgic...

    ALTRI SOTTOSTUDI:
    Una valutazione della sicurezza ed efficacia di CSL627 nella prevenzione ed il trattamento di sanguinamento durante procedure chirurgiche.L'obiettivo principale:dimostrare l'efficacia di CSL627...

    E.3Principal inclusion criteria
    - Diagnosis of severe hemophilia A defined as <1% FVIII:C documented in medical records. - Males between 18 and 65 years of age (Parts 1 and 2). - Males between 12 and 65 years of age (Part 3). - Subjects who have received or are currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have had >150 exposure days (EDs) with a FVIII product - Written informed consent for study participation obtained before undergoing any study specific procedures.
    - Diagnosi di grave emofilia A definita come &lt;1% FVIII:C documentato nelle cartelle cliniche. - Pazienti di sesso maschile tra i 18 e i 65 anni (Parti 1 e 2). - Pazienti di sesso maschile tra i 12 e i 65 anni (Parte 3). - Soggetti che hanno ricevuto o stanno ricevendo prodotti FVIII (FVIII plasmaderivato e/o ricombinante) e hanno avuto &gt;150 giorni di esposizione (ED) a un prodotto FVIII. - Consenso informato scritto per la partecipazione allo studio, ottenuto prima di sottoporre il paziente a procedure di studio specifiche.
    E.4Principal exclusion criteria
    - Any history of or current FVIII inhibitors - Any first order family history of FVIII inhibitors - Use of an Investigational Medicinal Product within 30 days prior to the first rFVIII administration. - Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to screening and 4 days prior to administration of rFVIII or reference product. - Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein. - Any known congenital or acquired coagulation disorder other than congenital FVIII deficiency. - Platelet count < 100,000/μL at screening. - HIV positive subjects with a CD4 count < 200/mm3, in their medical history or at screening if available results are older than one year. (HIV positive subjects may participate in the study and antiviral therapy are permitted, at the discretion of the Investigator). - Subject currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment. - Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) values > 5 times (x) the upper limit of normal (ULN) at Screening. - Subjects with serum creatinine values > 2 x ULN at Screening. - Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to Day 1. - Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to Day 1. - Demonstrated inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance. - Employee at the study site, or spouse/partner or relative of the investigator or subinvestigators. - Re-entry of subjects previously enrolled or participating in the current study. - Suspected inability (eg, language problems) or unwillingness to comply with study procedures. - Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study). - Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
    Storia di inibitori del FVIII, passata o attuale - Storia familiare di prim’ordine di inibitori del FVIII. - Utilizzo di un prodotto medicinale sperimentale nei 30 giorni precedenti la prima somministrazione di FVIII. - Somministrazione di crioprecipitato, sangue intero o plasma nei 30 giorni precedenti lo screening e nei 4 giorni precedenti la somministrazione di rFVIII o del prodotto di riferimento. - Ipersensibilità nota (reazione allergica o anafilassi) a qualsiasi prodotto FVIII o alle proteine di criceto. - Qualsiasi disturbo noto della coagulazione, congenito o acquisito, diverso dalla carenza congenita di FVIII. - Conta piastrinica &lt; 100.000/μL allo screening. - Soggetti HIV-positivi con una conta dei CD4 &lt; 200/mm3, nella loro storia medica o allo screening se i risultati disponibili risalgono a oltre un anno prima (i soggetti HIV-positivi possono partecipare allo studio e le terapie antivirali sono consentite, a discrezione dello Sperimentatore). - Soggetti che stanno ricevendo agenti immunomodulatori per via EV come immunoglobulina o trattamento cronico con corticosteroidi sistemici. - Soggetti con livelli sierici di aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) &gt; 5 volte (x) il limite superiore della norma (ULN) allo Screening. - Soggetti con valori di creatinina sierica &gt; 2 x ULN allo Screening. - Evidenza di trombosi, compresi trombosi venosa profonda, ictus, embolia polmonare, infarto del miocardio ed embolia arteriosa nei 3 mesi precedenti il Giorno 1. - Episodio di sanguinamento potenzialmente fatale o intervento di chirurgia maggiore o procedura chirurgica ortopedica nei 3 mesi precedenti il Giorno 1. - Incapacità dimostrata (es. problema di linguaggio o condizione mentale) o non disponibilità ad attenersi alle procedure di studio oppure storia di non compliance. - Dipendenti del centro di studio, oppure coniugi/partner o parenti dello sperimentatore o degli aiuto-sperimentatori. - Riammissione di soggetti arruolati in precedenza o partecipanti all’attuale studio. - Sospetta incapacità (es. problemi di linguaggio) o non disponibilità ad attenersi alle procedure di studio. - Condizione mentale che rende il soggetto (o il/i rappresentante/i legale/i del soggetto) incapace di comprendere la natura, le finalità e le possibili conseguenze dello studio). - Qualsiasi condizione che possa interferire con la valutazione dell’IMP o con la conduzione soddisfacente dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    The rate of treatment success for bleeding episodes defined as a rating of ''excellent'' or ''good'' on the investigator's overall clinical assessment of hemostatic efficacy four-point scale. The rate of inhibitor formation to FVIII evaluated from the time of first dose through the End of Study visit. For surgical sub-studytThe primary efficacy endpoint: -the rate of treatment success during the peri-operative surgical sub-study defined as an investigator rating of ''excellent'' or ''good'' on the four-point efficacy evaluation of surgical treatment scale.
    Il tasso di successo del trattamento degli episodi di sanguinamento definito “eccellente” o “buono” nella valutazione clinica complessiva dello sperimentatore in base alla scala a quattro punti per la valutazione dell’efficacia emostatica. Il tasso di formazione di inibitori del FVIII valutato dal momento della prima dose fino alla Visita di fine studio. Per il sottostudio chirurgico, l’endpoint di efficacia primaria è: - il tasso di successo del trattamento durante il sottostudio chirurgico perioperatorio definito “eccellente” o “buono” da parte dello sperimentatore in base alla scala a quattro punti per la valutazione dell’efficacia del trattamento chirurgico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    study duration up to 12 months Assessment on monthly visits. Months 1 to 6, 9 and 12.
    Durata dello studio fino a 12 mesi. Valutazione basata sulle visite mensili.Mesi da 1 a 6, 9 e 12.
    E.5.2Secondary end point(s)
    PK parameters for CSL627 and octocog alfa collected during Part 1 of the study including incremental recovery, AUC0–t, AUC0–∞, percent of area extrapolated, Cmax, Tmax, elimination constant, half-life (t1/2), AUMC0–∞, mean residence time (MRT), clearance (Cl), and volume of distribution at steady-state (Vss). The proportion of bleeding episodes requiring one, 2, 3 or > 3 infusions of CSL627 to achieve hemostasis. The safety assessment of CSL627 including AEs, SAEs, laboratory safety parameters (serum chemistry and hematology), antibodies to CSL627, pre- and post-infusion vital signs, and physical examination.
    Parametri farmacocinetici (PK) per CSL627 e octocog alfa raccolti durante la Parte 1 dello studio, compresi recupero incrementale, AUC0–t, AUC0–∞, percentuale dell’area estrapolata, Cmax, Tmax, costante di eliminazione, emivita (t1/2), AUMC0–∞, tempo medio di residenza (MRT), clearance (Cl) e volume della distribuzione a livelli stabili (Vss). La percentuale di episodi di sanguinamento che richiedono una, 2, 3 o > 3 infusioni di CSL627 per raggiungere l’emostasi. La valutazione di sicurezza di CSL627, compresi AE, SAE, parametri di sicurezza di laboratorio (esami ematochimici ed ematologici), anticorpi a CSL627, segni vitali pre- e post-infusione e visita medica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood draws for the full PK analysis will be at pre-dose (immendiately prior to the initial dose), then at intervals after infusion over 72 hours (0,5, 1, 4, 8, 10, 24, 28, 48 and 72 hours) measured by the CS and OC assays.
    I prelievi di sangue per le analisi farmacocinetiche complete avranno luogo alla visita pre-dose (immediatamente prima della dose iniziale), poi a intervalli post-infusione per 72 ore (0,5, 1, 4, 8, 10, 24, 28, 48 e 72 ore), misurati dalle analisi CS e OC.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    PK, Efficacy and Safety
    Farmacocinetica, Efficacia e Sicurezza
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Malaysia
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    ''LVLS'',
    ''LVLS'',
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months28
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 109
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 115
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who end their participation in the trial can return to standard therapy according to their health care scheme.
    I pazienti che terminano la loro partecipazione alla studio possono ritornare alla terapia standard prevista dallo schema di salute nazionale.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-30
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